Cleared Traditional

ARTEMIS LIGHT ENGINE

K141164 · Quest Medical Imaging · Gastroenterology & Urology

Mar 2015

Decision

315d

Days

Class 2

Risk

About This 510(k) Submission

K141164 is an FDA 510(k) clearance for the ARTEMIS LIGHT ENGINE, a Led Light Source (Class II — Special Controls, product code NTN), submitted by Quest Medical Imaging (Akron, US). The FDA issued a Cleared decision on March 16, 2015, 315 days after receiving the submission on May 5, 2014. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K141164 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 05, 2014
Decision Date	March 16, 2015
Days to Decision	315 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF

Device Classification

Product Code	NTN — Led Light Source
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.1500
Definition	Used To Provide Access, Illumination, And Allow Observation Or Manipulation Of Body Cavities, Hollow Organs, And Canals